Clinical Regulatory Associate

Pharmaron • Baltimore, MD

19d • Onsite

About The Position

Pharmaron is seeking a detail-oriented Clinical Regulatory Associate to manage essential clinical trial documentation, IRB submissions, and study start-up activities. This role is critical to ensuring compliance and smooth execution of clinical studies.

Requirements

• High school diploma required
• Entry-level experience in a clinical research environment required
• Strong organizational, communication, and time management skills
• High attention to detail and ability to manage multiple priorities

Nice To Haves

• Associate degree preferred
• Knowledge of GCP/GLP standards preferred

Responsibilities

• Create and maintain Investigator Site Files and Trial Master File
• Prepare and submit initial and continuing IRB submissions
• Generate essential study documents (FDA 1572, Financial Disclosure Forms, etc.)
• Report deviations, violations, and Serious Adverse Events to the IRB
• Coordinate protocol-specific staff training and delegation logs
• Maintain current approved protocols, consent forms, and Investigator Brochures
• Support monitoring visits and study closeout activities
• Ensure compliance with GCP, GLP, and internal procedures

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED